Write-up:Information has been received from a physician concerning a 6 month old male, that was born with a fractured left clavicle because he was big at birth, and who had no other history other than sniffles, who was vaccinated with a first, second, and third 2"ml oral dose of rotavirus reassortant vaccine live (human-bovine) on 02-Jul-2007 (Lot# 656845/0409U), 05-Sep-2007 (Lot# 656845/0409U), and 14-Nov-2007 (Lot# 657665/1460U), respectively. Concomitant therapy included diphtheria toxoid (+) pertussis acellul

Write-up:Information has been received from a physician concerning a 6 month old male, that was born with a fractured left clavicle because he was big at birth, and who had no other history other than sniffles, who was vaccinated with a first, second, and third 2"ml2 ml oral dose of rotavirus reassortant vaccine live (human-bovine) on 02-Jul-2007 (Lot# 656845/0409U), 05-Sep-2007 (Lot# 656845/0409U), and 14-Nov-2007 (Lot# 657665/1460U), respectively. Concomitant therapy included diphtheria toxoid (+) pertussis acellulacellular vaccine (unspecified) (+) tetanus toxoid, Hib conj vaccine (OMPC) (manufacturer unknown), pneumococcal conj vaccine (unspecified) and influenza virus vaccine (unspecified). "Eleven days later," on 25-Nov-2007 the patient was throwing up what looked like the color of coffee granules and continued to throw up. The patient''s mother called the physician. On 26-Nov-2007 the patient''s mother took the patient to the hospital and was hospitalized. At the time the patient was experiencing vomiting and had on loose stool. It was noted that all kinds of tests were performed. Blood work showed a high white blood count. The patient was put on IV fluids and was dehydrated. The patient had an x-ray of the intestine and an ultrasound. On 28-Nov-2007, at 9:00 a.m., the patient was rushed to a second hospital and was diagnosed with intussusception. It was noted that all types of tests were performed, and finally a jelly-like mucuos blood stool was expelled. The patient''s mother stated that seven barium enema procedures were performed on the patient, and the last one worked. There was no surgery. The patient was discharged from the hospital on 30-Nov-2007 at 12:00 p.m. The patient''s mother indicated that she was nursing the child and he seemed okay, but later started bucking and thrashing like he was in pain. The patient''s mother took the patient back to the hospital and they observed him for several hours and then he was released, not hospitalized. The patient''s mother indicated that the child was recovering but

Write-up:Information has been received from a physician concerning a 6 month old male, that was born with a fractured left clavicle because he was big at birth, and who had no other history other than sniffles, who was vaccinated with a first, second, and third 2 ml oral dose of rotavirus reassortant vaccine live (human-bovine) on 02-Jul-2007 (Lot# 656845/0409U), 05-Sep-2007 (Lot# 656845/0409U), and 14-Nov-2007 (Lot# 657665/1460U), respectively. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, Hib conj vaccine (OMPC) (manufacturer unknown), pneumococcal conj vaccine (unspecified) and influenza virus vaccine (unspecified). "Eleven days later," on 25-Nov-2007 the patient was throwing up what looked like the color of coffee granules and continued to throw up. The patient''s mother called the physician. On 26-Nov-2007 the patient''s mother took the patient to the hospital and was hospitalized. At the time the patient was experiencing vomiting and had on loose stool. It was noted that all kinds of tests were performed. Blood work showed a high white blood count. The patient was put on IV fluids and was dehydrated. The patient had an x-ray of the intestine and an ultrasound. On 28-Nov-2007, at 9:00 a.m., the patient was rushed to a second hospital and was diagnosed with intussusception. It was noted that all types of tests were performed, and finally a jelly-like mucuos blood stool was expelled. The patient''s mother stated that seven barium enema procedures were performed on the patient, and the last one worked. There was no surgery. The patient was discharged from the hospital on 30-Nov-2007 at 12:00 p.m. The patient''s mother indicated that she was nursing the child and he seemed okay, but later started bucking and thrashing like he was in pain. The patient''s mother took the patient back to the hospital and they observed him for several hours and then he was released, not hospitalized. The patient''s mother indicated that the child was recovering but

Write-up:Information has been received from a physician concerning a 6 month old male, that was born with a fractured left clavicle because he was big at birth, and who had no other history other than sniffles, who was vaccinated with a first, second, and third 2 ml oral dose of rotavirus reassortant vaccine live (human-bovine) on 02-Jul-2007 (Lot# 656845/0409U), 05-Sep-2007 (Lot# 656845/0409U), and 14-Nov-2007 (Lot# 657665/1460U), respectively. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, Hib conj vaccine (OMPC) (manufacturer unknown), pneumococcal conj vaccine (unspecified) and influenza virus vaccine (unspecified). "Eleven days later," on 25-Nov-2007 the patient was throwing up what looked like the color of coffee granules and continued to throw up. The patient''s mother called the physician. On 26-Nov-2007 the patient''s mother took the patient to the hospital and was hospitalized. At the time the patient was experiencing vomiting and had on loose stool. It was noted that all kinds of tests were performed. Blood work showed a high white blood count. The patient was put on IV fluids and was dehydrated. The patient had an x-ray of the intestine and an ultrasound. On 28-Nov-2007, at 9:00 a.m., the patient was rushed to a second hospital and was diagnosed with intussusception. It was noted that all types of tests were performed, and finally a jelly-like mucuos blood stool was expelled. The patient''s mother stated that seven barium enema procedures were performed on the patient, and the last one worked. There was no surgery. The patient was discharged from the hospital on 30-Nov-2007 at 12:00 p.m. The patient''s mother indicated that she was nursing the child and he seemed okay, but later started bucking and thrashing like he was in pain. The patient''s mother took the patient back to the hospital and they observed him for several hours and then he was released, not hospitalized. The patient''s mother indicated that the child was recovering but

Write-up:Information has been received from a physician concerning a 6 month old male, that was born with a fractured left clavicle because he was big at birth, and who had no other history other than sniffles, who was vaccinated with a first, second, and third 2 ml oral dose of rotavirus reassortant vaccine live (human-bovine) on 02-Jul-2007 (Lot# 656845/0409U), 05-Sep-2007 (Lot# 656845/0409U), and 14-Nov-2007 (Lot# 657665/1460U), respectively. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, Hib conj vaccine (OMPC) (manufacturer unknown), pneumococcal conj vaccine (unspecified) and influenza virus vaccine (unspecified). "Eleven days later," on 25-Nov-2007 the patient was throwing up what looked like the color of coffee granules and continued to throw up. The patient''s mother called the physician. On 26-Nov-2007 the patient''s mother took the patient to the hospital and was hospitalized. At the time the patient was experiencing vomiting and had on loose stool. It was noted that all kinds of tests were performed. Blood work showed a high white blood count. The patient was put on IV fluids and was dehydrated. The patient had an x-ray of the intestine and an ultrasound. On 28-Nov-2007, at 9:00 a.m., the patient was rushed to a second hospital and was diagnosed with intussusception. It was noted that all types of tests were performed, and finally a jelly-like mucuos blood stool was expelled. The patient''s mother stated that seven barium enema procedures were performed on the patient, and the last one worked. There was no surgery. The patient was discharged from the hospital on 30-Nov-2007 at 12:00 p.m. The patient''s mother indicated that she was nursing the child and he seemed okay, but later started bucking and thrashing like he was in pain. The patient''s mother took the patient back to the hospital and they observed him for several hours and then he was released, not hospitalized. The patient''s mother indicated that the child was recovering but

Write-up:Information has been received from a physician concerning a 6 month old male, that was born with a fractured left clavicle because he was big at birth, and who had no other history other than sniffles, who was vaccinated with a first, second, and third 2 ml oral dose of rotavirus reassortant vaccine live (human-bovine) on 02-Jul-2007 (Lot# 656845/0409U), 05-Sep-2007 (Lot# 656845/0409U), and 14-Nov-2007 (Lot# 657665/1460U), respectively. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, Hib conj vaccine (OMPC) (manufacturer unknown), pneumococcal conj vaccine (unspecified) and influenza virus vaccine (unspecified). "Eleven days later," on 25-Nov-2007 the patient was throwing up what looked like the color of coffee granules and continued to throw up. The patient''s mother called the physician. On 26-Nov-2007 the patient''s mother took the patient to the hospital and was hospitalized. At the time the patient was experiencing vomiting and had on loose stool. It was noted that all kinds of tests were performed. Blood work showed a high white blood count. The patient was put on IV fluids and was dehydrated. The patient had an x-ray of the intestine and an ultrasound. On 28-Nov-2007, at 9:00 a.m., the patient was rushed to a second hospital and was diagnosed with intussusception. It was noted that all types of tests were performed, and finally a jelly-like mucuos blood stool was expelled. The patient''s mother stated that seven barium enema procedures were performed on the patient, and the last one worked. There was no surgery. The patient was discharged from the hospital on 30-Nov-2007 at 12:00 p.m. The patient''s mother indicated that she was nursing the child and he seemed okay, but later started bucking and thrashing like he was in pain. The patient''s mother took the patient back to the hospital and they observed him for several hours and then he was released, not hospitalized. The patient''s mother indicated that the child was recovering but

Write-up:Information has been received from a physician concerning a 6 month old male, that was born with a fractured left clavicle because he was big at birth, and who had no other history other than sniffles, who was vaccinated with a first, second, and third 2 ml oral dose of rotavirus reassortant vaccine live (human-bovine) on 02-Jul-2007 (Lot# 656845/0409U), 05-Sep-2007 (Lot# 656845/0409U), and 14-Nov-2007 (Lot# 657665/1460U), respectively. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, Hib conj vaccine (OMPC) (manufacturer unknown), pneumococcal conj vaccine (unspecified) and influenza virus vaccine (unspecified). "Eleven days later," on 25-Nov-2007 the patient was throwing up what looked like the color of coffee granules and continued to throw up. The patient''s mother called the physician. On 26-Nov-2007 the patient''s mother took the patient to the hospital and was hospitalized. At the time the patient was experiencing vomiting and had on loose stool. It was noted that all kinds of tests were performed. Blood work showed a high white blood count. The patient was put on IV fluids and was dehydrated. The patient had an x-ray of the intestine and an ultrasound. On 28-Nov-2007, at 9:00 a.m., the patient was rushed to a second hospital and was diagnosed with intussusception. It was noted that all types of tests were performed, and finally a jelly-like mucuos blood stool was expelled. The patient''s mother stated that seven barium enema procedures were performed on the patient, and the last one worked. There was no surgery. The patient was discharged from the hospital on 30-Nov-2007 at 12:00 p.m. The patient''s mother indicated that she was nursing the child and he seemed okay, but later started bucking and thrashing like he was in pain. The patient''s mother took the patient back to the hospital and they observed him for several hours and then he was released, not hospitalized. The patient''s mother indicated that the child was recovering but

Write-up:Information has been received from a physician concerning a 6 month old male, that was born with a fractured left clavicle because he was big at birth, and who had no other history other than sniffles, who was vaccinated with a first, second, and third 2 ml oral dose of rotavirus reassortant vaccine live (human-bovine) on 02-Jul-2007 (Lot# 656845/0409U), 05-Sep-2007 (Lot# 656845/0409U), and 14-Nov-2007 (Lot# 657665/1460U), respectively. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, Hib conj vaccine (OMPC) (manufacturer unknown), pneumococcal conj vaccine (unspecified) and influenza virus vaccine (unspecified). "Eleven days later," on 25-Nov-2007 the patient was throwing up what looked like the color of coffee granules and continued to throw up. The patient''s mother called the physician. On 26-Nov-2007 the patient''s mother took the patient to the hospital and was hospitalized. At the time the patient was experiencing vomiting and had on loose stool. It was noted that all kinds of tests were performed. Blood work showed a high white blood count. The patient was put on IV fluids and was dehydrated. The patient had an x-ray of the intestine and an ultrasound. On 28-Nov-2007, at 9:00 a.m., the patient was rushed to a second hospital and was diagnosed with intussusception. It was noted that all types of tests were performed, and finally a jelly-like mucuos blood stool was expelled. The patient''s mother stated that seven barium enema procedures were performed on the patient, and the last one worked. There was no surgery. The patient was discharged from the hospital on 30-Nov-2007 at 12:00 p.m. The patient''s mother indicated that she was nursing the child and he seemed okay, but later started bucking and thrashing like he was in pain. The patient''s mother took the patient back to the hospital and they observed him for several hours and then he was released, not hospitalized. The patient''s mother indicated that the child was recovering but was still somewhat traumatized by all the events and was weak and clinging. The physician did not think that the patient''s intussusception was realted to rotavirus reassortant vaccine live (human-bovine). No product quality complaint was involved. No other information was provided. The patient''s intussusception was considered to be an other important medical event. Additional information has been requested. 1/16/08-records received for DOS 11/28-11/29/07 and 11/29-11/30/07-DC DX: Intussusception. Successful reduction by barium enema. Returned the same evening for C/O crying and vomiting. Observed and discharged. illness began 3 days prior to admission with vomiting, fussy, resless and crying out in sleep. Low grade fever. Emesis became dark brown and guaiac positive. Passed blood mucousy stool.

Write-up:Information has been received from a physician concerning a 6 month old male, that was born with a fractured left clavicle because he was big at birth, and who had no other history other than sniffles, who was vaccinated with a first, second, and third 2 ml oral dose of rotavirus reassortant vaccine live (human-bovine) on 02-Jul-2007 (Lot# 656845/0409U), 05-Sep-2007 (Lot# 656845/0409U), and 14-Nov-2007 (Lot# 657665/1460U), respectively. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, Hib conj vaccine (OMPC) (manufacturer unknown), pneumococcal conj vaccine (unspecified) and influenza virus vaccine (unspecified). "Eleven days later," on 25-Nov-2007 the patient was throwing up what looked like the color of coffee granules and continued to throw up. The patient''s mother called the physician. On 26-Nov-2007 the patient''s mother took the patient to the hospital and was hospitalized. At the time the patient was experiencing vomiting and had on loose stool. It was noted that all kinds of tests were performed. Blood work showed a high white blood count. The patient was put on IV fluids and was dehydrated. The patient had an x-ray of the intestine and an ultrasound. On 28-Nov-2007, at 9:00 a.m., the patient was rushed to a second hospital and was diagnosed with intussusception. It was noted that all types of tests were performed, and finally a jelly-like mucuos blood stool was expelled. The patient''s mother stated that seven barium enema procedures were performed on the patient, and the last one worked. There was no surgery. The patient was discharged from the hospital on 30-Nov-2007 at 12:00 p.m. The patient''s mother indicated that she was nursing the child and he seemed okay, but later started bucking and thrashing like he was in pain. The patient''s mother took the patient back to the hospital and they observed him for several hours and then he was released, not hospitalized. The patient''s mother indicated that the child was recovering but was still somewhat traumatized by all the events and was weak and clinging. The physician did not think that the patient''s intussusception was realted to rotavirus reassortant vaccine live (human-bovine). No product quality complaint was involved. No other information was provided. The patient''s intussusception was considered to be an other important medical event. Additional information has been requested. 1/16/08-records received for DOS 11/28-11/29/07 and 11/29-11/30/07-DC DX: Intussusception. Successful reduction by barium enema. Returned the same evening for C/O crying and vomiting. Observed and discharged. illness began 3 days prior to admission with vomiting, fussy, resless and crying out in sleep. Low grade fever. Emesis became dark brown and guaiac positive. Passed blood mucousy stool.

Write-up:Information has been received from a physician concerning a 6 month old male, that was born with a fractured left clavicle because he was big at birth, and who had no other history other than sniffles, who was vaccinated with a first, second, and third 2 ml oral dose of rotavirus reassortant vaccine live (human-bovine) on 02-Jul-2007 (Lot# 656845/0409U), 05-Sep-2007 (Lot# 656845/0409U), and 14-Nov-2007 (Lot# 657665/1460U), respectively. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, Hib conj vaccine (OMPC) (manufacturer unknown), pneumococcal conj vaccine (unspecified) and influenza virus vaccine (unspecified). "Eleven days later," on 25-Nov-2007 the patient was throwing up what looked like the color of coffee granules and continued to throw up. The patient''s mother called the physician. On 26-Nov-2007 the patient''s mother took the patient to the hospital and was hospitalized. At the time the patient was experiencing vomiting and had on loose stool. It was noted that all kinds of tests were performed. Blood work showed a high white blood count. The patient was put on IV fluids and was dehydrated. The patient had an x-ray of the intestine and an ultrasound. On 28-Nov-2007, at 9:00 a.m., the patient was rushed to a second hospital and was diagnosed with intussusception. It was noted that all types of tests were performed, and finally a jelly-like mucuos blood stool was expelled. The patient''s mother stated that seven barium enema procedures were performed on the patient, and the last one worked. There was no surgery. The patient was discharged from the hospital on 30-Nov-2007 at 12:00 p.m. The patient''s mother indicated that she was nursing the child and he seemed okay, but later started bucking and thrashing like he was in pain. The patient''s mother took the patient back to the hospital and they observed him for several hours and then he was released, not hospitalized. The patient''s mother indicated that the child was recovering but was still somewhat traumatized by all the events and was weak and clinging. The physician did not think that the patient''s intussusception was realted to rotavirus reassortant vaccine live (human-bovine). No product quality complaint was involved. No other information was provided. The patient''s intussusception was considered to be an other important medical event. Additional information has been requested. 1/16/08-records received for DOS 11/28-11/29/07 and 11/29-11/30/07-DC DX: Intussusception. Successful reduction by barium enema. Returned the same evening for C/O crying and vomiting. Observed and discharged. illness began 3 days prior to admission with vomiting, fussy, resless and crying out in sleep. Low grade fever. Emesis became dark brown and guaiac positive. Passed blood mucousy stool.